Pa June 19, Center for Drug Evaluation (CDE) ya National Medical Products Administration (NMPA) inalengeza kuti jakisoni wa LM-108 wa Livzon Pharmaceutical waperekedwa kuti uphatikizidwe mu njira yopangira chithandizo. Kuphatikiza kwa jakisoni wa Kefeqibai monoclonal antibody (LM-108) ndi toripalimab kukuganiziridwa kuti kuchiritse odwala omwe ali ndi advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma omwe ali ndi CCR8-positive ndipo adalephera chithandizo choyambirira cha mzere woyamba.
LM-108 ndi antibody yatsopano ya Fc-optimized, anti-CCR8 monoclonal antibody yomwe imachotsa Tregs zomwe zimalowa m'thupi.
Zokhudza CCR8:
CCR8 (chemokine receptor 8) ndi membala wa gulu la chemokine receptor lomwe lili pansi pa banja la G protein-coupled receptor (GPCR). Kafukufuku wakale adawonetsa kuti CCR8 imapezeka m'maselo ochepa a m'magazi ndi minofu yabwinobwino, koma imawonjezeka makamaka m'matenda olowa m'mimba mwa khansa zosiyanasiyana kuphatikizapo khansa ya m'mawere, khansa ya m'matumbo, ndi khansa ya m'mapapo. Ma antibodies a Anit-CCR8 amatha kuletsa kuchepa kwa ma Tregs olowa m'mimba mwa khansa, motero kukulitsa chitetezo cha mthupi chotsutsana ndi chotupa ndikuletsa kukula kwa chotupa.
Pa Msonkhano Wapachaka wa American Society of Clinical Oncology (ASCO) wa 2024, kusanthula kophatikizana kwa maphunziro atatu a Gawo 1/2 pa kuphatikiza kwa LM-108 ndi mankhwala oletsa PD-1 mwa odwala khansa ya m'mimba kunaperekedwa.
Njira: Odwala oyenerera omwe ali ndi khansa ya m'mimba omwe adalandira chithandizo cha LM-108 pamodzi ndi anti-PD-1 antibody adaphatikizidwa mu kusanthulaku. Odwala adalandira LM-108 kudzera m'mitsempha pamlingo wa 3 mg/kg Q2W, 6 mg/kg Q3W, kapena 10 mg/kg Q3W kuphatikiza anti-PD-1 antibody (intravenous pembrolizumab 200 mg Q3W kapena 400 mg Q6W kapena toripalimab 240 mg Q3W). Mapeto oyamba anali ORR yowunikidwa ndi ofufuza pa RECIST v1.1. Mapeto achiwiri adaphatikizapo chitetezo, zotsatira zina zogwira ntchito, ndi kusanthula kwa biomarkers. Tsiku lomaliza la kusanthula komwe kwaphatikizidwa linali Disembala 25, 2023.
Zotsatira: Odwala 48 omwe ali ndi khansa ya m'mimba (zaka zapakati: zaka 60.5; amuna: 72.9%) ochokera ku China, USA, ndi Australia adapatsidwa chithandizo cha ≥ mlingo umodzi wa LM-108 pamodzi ndi pembrolizumab kapena toripalimab. Odwala ambiri (n = 47, 97.9%) adalandira chithandizo chimodzi chotsutsana ndi khansa m'mbuyomu, ndipo 43 (89.6%) adalandira chithandizo cha anti-PD-1 m'mbuyomu. Zochitika zoyipa zokhudzana ndi chithandizo (TRAEs) zidachitika mwa odwala 39 (81.3%), pomwe zochitika zodziwika kwambiri (≥15%) zinali kuwonjezeka kwa alanine transaminase (25.0%), kuwonjezeka kwa aspartate transaminase (22.9%), kuchepa kwa maselo oyera m'magazi (22.9%), kuchepa kwa magazi m'thupi (16.7%). Ma TRAE a Giredi ≥ 3 adachitika mwa odwala 18 (37.5%), zochitika zodziwika kwambiri (≥ 4%) zinali kuchepa kwa magazi m'thupi (8.3%), kuchuluka kwa lipase (4.2%), ziphuphu (4.2%), ndi kuchuluka kwa ma lymphocyte kunachepa (4.2%). Pakati pa odwala 36 omwe amayesedwa bwino pamankhwala onse, ORR inali 36.1% ndipo DCR inali 72.2%. PFS yapakati inali miyezi 6.53. Pakati pa odwala 11 omwe matenda awo adapita patsogolo pa chithandizo choyamba, ORR inali 63.6% ndipo DCR inali 81.8%. Mwa odwala 11 omwe adapita patsogolo pa chithandizo choyamba, 8 anali ndi CCR8 yokwera. Pakati pa odwala 8 awa, ORR inali 87.5% ndipo DCR inali 100%, ndipo CR imodzi, 6 PR, ndi SD imodzi idawonedwa.
Mapeto: LM-108 pamodzi ndi antibody yotsutsana ndi PD-1 inasonyeza kuti imagwira ntchito bwino polimbana ndi chotupa mwa odwala khansa ya m'mimba yomwe inali yotsutsana ndi mankhwala otsutsana ndi PD-1. Mankhwala ophatikizanawo anali ololedwa bwino.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Nthawi yotumizira: Juni-24-2025